(57 days)
The intended use of Ciba Corning Ciba Corning ACS:180 DPD Assay is for the quantitative of deoxypyridinoline (DPD) in urine using the Ciba Corning ACS:180 automated chemiluminescence systems
The Ciba Corning ACS:180 DPD assay is a competitive immunoassay using direct, competitive chemiluminescent technology. DPD in the patient sample competes with pvridinoline bound to the paramagnetic particles in the Solid Phase for a limited amount of monoclonal mouse anti-DPD antibody in the Lite Reagent. The monoclonal mouse anti-DPD is bound to goat antibody labeled with acridinium ester. An inverse relationship exists between the amount of DPD present in the sample and the amount of relative light units (RLUs) detected by the system.
This document describes the Ciba Corning ACS:180 DPD Assay, an in-vitro diagnostic device for measuring deoxypyridinoline (DPD) in urine. As a diagnostic device, the acceptance criteria and performance are related to analytical characteristics rather than diagnostic accuracy as would be found in imaging AI. Therefore, I will adapt the requested sections to align with the provided information.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | Minimum detectable concentration should be clinically relevant. | Minimum detectable concentration of 5.0 nM. Measures DPD concentrations up to 350 nM. |
| Method Comparison | Good correlation with an established alternate method (e.g., ELISA) | Correlation coefficient (r) = 0.961 for 752 urine samples (6 to 350 nM). Equation: ACS:180 DPD = 1.05 (alternate method) + 2.13 |
| Precision | Acceptable within-run and total precision for clinical use. | Total precision (%CV) ranged from 2.84% to 9.76%. |
2. Sample Size Used for the Test Set and Data Provenance
For the method comparison study:
- Sample Size: 752 urine samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a 510(k) submission from a US company for a new diagnostic device, it typically implies data collected in a clinical lab setting, likely prospective or from stored biobank samples.
For the sensitivity and precision studies:
- Sample Size (Sensitivity): 20 replicate determinations of the DPD zero standard.
- Sample Size (Precision): Not explicitly stated, but typically involves multiple replicates across different concentrations and runs.
- Data Provenance: Not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this type of in-vitro diagnostic device study. Ground truth is established by the results of the reference (alternate) method and the physical properties of the assay, not expert interpretation of images or patient data.
4. Adjudication Method for the Test Set
This is not applicable to this type of in-vitro diagnostic device study. Adjudication typically refers to resolving discrepancies between multiple human readers or between human readers and an AI; this study compares analytical results between two assays.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a laboratory assay, not an AI for human interpretation or decision support. No human readers are involved in the performance of the assay itself.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the performance characteristics (sensitivity, method comparison, precision) described are for the Ciba Corning ACS:180 DPD Assay standalone performance. It is an automated chemiluminescence system, operating independently to produce DPD concentration values.
7. The Type of Ground Truth Used
- Sensitivity: The ground truth for determining the minimum detectable concentration is implicitly the "zero standard" (a sample with no DPD) and statistical analysis (two standard deviations less than the mean RLUs).
- Method Comparison: The "ground truth" or reference standard for comparison was an "alternate ELISA method" (Pyrilinks®-D, the predicate device), as the study aims to show correlation and agreement between the new assay and an established method.
- Precision: The ground truth for precision is the statistical variability of the assay's own measurements when performed repeatedly.
8. The Sample Size for the Training Set
This is not applicable in the context of traditional in-vitro diagnostic assays, especially those using competitive immunoassay technology. These devices are developed and optimized through chemical and biochemical engineering, not through machine learning training sets. Therefore, there is no "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this type of device, this question is not applicable. The development and optimization of the assay would involve experimental validation steps to ensure robust and accurate chemical reactions and detection, rather than establishing ground truth for a training dataset.
§ 862.1400 Hydroxyproline test system.
(a)
Identification. A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.